我国药品召回制度研究

发布时间：2018-03-31 08:42

本文选题：缺陷药品　切入点：药品召回　出处：《西南政法大学》2014年硕士论文

【摘要】：近年来，随着国家对药品安全工作的逐步重视，安全有效用药的理念越来越深入人心。现代医药技术的发展促进了制药企业研发能力不断提升，新研发的药品数量逐年递增，这对提高人类抵御疾病的能力、提升生活品质具有重要意义。但是，药品的复杂性与危险性也与日俱增，缺陷药品给消费者造成损害的可能性也随之大增。在药品市场中，消费者的不确定性和广泛性决定了国家必须对药品市场实施严格监管。药品召回作为一种强化企业责任的预警措施，在保障公众安全用药、维护社会公共利益方面发挥着重要作用。 2007年颁布实施的《药品召回管理办法》标志着我国药品召回制度的正式建立，这不仅可以在更大程度上强化制药企业的诚信和责任意识，保障公众用药安全，而且通过政府和市场的双重调节也可以更好地维护市场经济秩序。但是，法律制度的完善是一个逐步推进的过程，近年来很多与药品相关的公共安全案件，如强生频发的药品召回事件、毒胶囊事件、康泰疫苗事件都告诉我们要重视药品召回制度的完善和发展。在高度发达的市场经济条件下，只有建立更加完善的法律制度和安全保障机制，公众才能享受到高科技带来的物质文明。新的医疗改革正在进行，，对药品市场的研究逐渐成为热点。综上，本文选择药品召回问题作为研究对象。本文共分为四个部分：第一部分主要是对美国强生频发的药品召回事件作出数据分析，从而引出药品召回问题。通过分析强生连年出现的各类药品召回事件和强生屡次将中国排除在药品召回的范围之外的事实得出：即便制药水平不断进步，缺陷药品仍然不能完全避免，我国虽然已经实施了药品召回制度，但与国外发达国家相比，我国的药品召回制度及相关配套制度仍然存在不足。第二部分主要是对药品召回制度进行概述。首先，对我国现行药品召回的含义进行解读；其次，介绍药品召回制度在国内国外的起源与发展；最后，从维护公众健康、企业信誉和市场秩序三方面总结药品召回制度的意义。第三部分主要是分析我国药品召回制度在实践中存在的三大问题：缺陷药品的定义不明确、我国药品召回主体结构存在不足及我国药品召回信息公开制度不健全。第四部分主要是针对第三部分所提出的三大问题提出完善建议：首先，建立切实可行的缺陷药品认定标准，明确缺陷药品的内涵与外延；其次，完善药品召回主体结构，建立缺陷药品管理系统。最后，统一药品召回信息公开制度，加强与外部的沟通交流。结语部分指出我国虽然已经建立了药品召回制度，但在实际运行过程中仍然存在欠缺，药品召回制度的完善过程任重而道远，需要社会各界的共同努力。
[Abstract]:In recent years, with the country pay more and more attention to drug safety, the concept of safe and effective drug use is more and more popular.The development of modern medicine technology has promoted the development of pharmaceutical enterprises'R & D ability and the quantity of new drugs has been increasing year by year, which is of great significance to improve the ability of human beings to resist diseases and improve the quality of life.However, the complexity and danger of drugs are increasing, and the possibility of damage caused by defective drugs to consumers is also increasing.In the pharmaceutical market, the uncertainty and universality of consumers determine that the country must strictly supervise the drug market.Drug recall, as an early warning measure to strengthen corporate responsibility, plays an important role in safeguarding the public safety of drug use and safeguarding the public interest.The "Drug recall Management measures" promulgated in 2007 marks the formal establishment of the drug recall system in China, which can not only strengthen the sense of honesty and responsibility of pharmaceutical enterprises to a greater extent, and ensure the safety of drug use by the public.And through the dual regulation of the government and the market can better maintain the order of the market economy.However, the improvement of the legal system is a gradual process. In recent years, many drug-related public safety cases, such as the frequent drug recalls by Johnson and the poison capsule incident,Kang Tai vaccine incident tells us to attach importance to the improvement and development of drug recall system.Under the condition of highly developed market economy, only by establishing a more perfect legal system and security mechanism can the public enjoy the material civilization brought by high technology.The new medical reform is under way, and the research on the drug market is becoming a hot spot.In summary, this paper chooses the drug recall problem as the research object.This paper is divided into four parts:The first part is mainly to make the data analysis to the American Johnson frequent drug recall event, thus leads to the drug recall question.Through the analysis of the various drug recalls that have occurred in successive years by Johnson and the fact that Johnson has repeatedly excluded China from the scope of drug recalls, it is concluded that even if the pharmaceutical level continues to improve, defective drugs still cannot be completely avoided.Although the drug recall system has been implemented in our country, compared with the developed countries, there are still some deficiencies in the drug recall system and related supporting system in our country.The second part is an overview of drug recall system.First of all, the meaning of current drug recall in China is interpreted; secondly, the origin and development of drug recall system at home and abroad are introduced; finally, from the maintenance of public health,The significance of drug recall system is summarized in three aspects: enterprise reputation and market order.The third part mainly analyzes the three problems existing in the practice of drug recall system in our country: the definition of defective drugs is not clear, the main structure of drug recall in our country is insufficient, and the disclosure system of drug recall information in our country is not perfect.The fourth part is mainly aimed at the three major problems put forward in the third part: first, to establish practical standards for the identification of defective drugs, to clarify the connotation and extension of defective drugs; secondly, to improve the main structure of drug recall.Establish defect drug management system.Finally, unified drug recall information disclosure system, strengthen communication with the outside.The conclusion points out that although the drug recall system has been established in our country, there are still deficiencies in the actual operation. The improvement process of the drug recall system has a long way to go and needs the joint efforts of all walks of life.
【学位授予单位】：西南政法大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D922.16

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